RRD MODEL AND SERVICES

Quality

RRD offers end-to-end quality services through:

  • Critical quality planning encompassing all stages of product development
  • Implementing Quality by Design (QbD) principles throughout all critical development functions
  • Continuously assessing quality through audits and tracking/optimizing Key Performace Indicators (KPIs)

Value

Achieving milestones while minimizing program risk

Identify, manage, and qualify vendors

Establish phase-appropriate quality standards

QbD to ensure quality data and documentation

Total quality management to achieve successful regulatory outcomes

“Without a standard there is no logical basis for making a decision or taking action.”

Joseph M. Juran

Quality Services

Quality System Planning

  • Conduct procedure and system gap analyses
  • Determine appropriate QMS for phase/purpose
  • NDA readiness

Nonclinical and Clinical Study Compliance and Oversight

  • Study-specific quality support tailored to needs
  • End-to-end execution
  • Manage vendors and IP logistics

GxP Training

  • Program team training, including lab & CMC activities
  • Establish complaint procedures
  • Audit preparation – agency/pharma

CMC Support and Oversight

  • Establish quality agreements with CDMO & testing labs
  • Real-time problem identification & solutions
  • Review executed manufacturing & testing records
  • Support lot release

Audit and Qualification Support

Vendor Identification and Qualification

  • GLP – preclinical, R&D assay development, PK/PD
  • GCP – CRO, site selection, bioanalytical lab support
  • GMP – CDMO, fill/finish, labeling, and stability support

Risk-based Vendor Management

  • Initial qualification through interim requalification
  • Management of ad hoc “for cause” audits to address GxP issues
  • Global review of applicable regulations FDA, EMA, ICH Q10 etc

Validation Engineering Assessment

  • IQ/OQ/PQ review of systems and equipment for CMC activities
  • Support for electronic systems (eTMF, ClinSpark, lab management software)

e-QMS and Data Room Hosting

Oversight/Management of Controlled Documentation to Demonstrate Clinical and Manufacturing Process Compliance

  • Facilitate due diligence activities by investors & business development
  • Facilitate regulatory authority or 3rd-party audits
  • 21 CFR Part 11 & GDPR compliant
  • Document repository for controlled development and supporting materials
  • Electronic storage to facilitate activities across time zones and geographies
  • Cloud-based infrastructure that can be leveraged on PC or mobiles with end-to-end encryption and cyber security controls
  • Real-time support for back-end, document troubleshooting and user support for client requests

Oversight/Management of Controlled Documentation to Demonstrate Clinical and Manufacturing Process Compliance

  • Facilitate due diligence activities by investors & business development
  • Facilitate regulatory authority or 3rd-party audits
  • 21 CFR Part 11 & GDPR compliant
  • Document repository for controlled development and supporting materials
  • Electronic storage to facilitate activities across time zones and geographies
  • Cloud-based infrastructure that can be leveraged on PC or mobiles with end-to-end encryption and cyber security controls
  • Real-time support for back-end, document troubleshooting and user support for client requests